Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea

November 27, 2013 updated by: Boehringer Ingelheim

Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).

This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.

Study Overview

Status

Completed

Conditions

Detailed Description

Study Design:

Study Type

Observational

Enrollment (Actual)

1296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Amberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Anklam, Germany
        • Boehringer Ingelheim Investigational Site
      • Aschau, Germany
        • Boehringer Ingelheim Investigational Site
      • Auerbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Augsburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Backnang, Germany
        • Boehringer Ingelheim Investigational Site
      • Bad Doberan, Germany
        • Boehringer Ingelheim Investigational Site
      • Bad Lippspringe, Germany
        • Boehringer Ingelheim Investigational Site
      • Bad Oeynhausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Bad Soden, Germany
        • Boehringer Ingelheim Investigational Site
      • Bad Wörishofen, Germany
        • Boehringer Ingelheim Investigational Site
      • Beelitz, Germany
        • Boehringer Ingelheim Investigational Site
      • Bensheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Bergisch Gladbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site
      • Biberach, Germany
        • Boehringer Ingelheim Investigational Site
      • Bochum, Germany
        • Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • Boehringer Ingelheim Investigational Site
      • Braunschweig, Germany
        • Boehringer Ingelheim Investigational Site
      • Breisach, Germany
        • Boehringer Ingelheim Investigational Site
      • Bremen, Germany
        • Boehringer Ingelheim Investigational Site
      • Bremerhaven, Germany
        • Boehringer Ingelheim Investigational Site
      • Bruchsal, Germany
        • Boehringer Ingelheim Investigational Site
      • Buchholz, Germany
        • Boehringer Ingelheim Investigational Site
      • Bünde, Germany
        • Boehringer Ingelheim Investigational Site
      • Calw, Germany
        • Boehringer Ingelheim Investigational Site
      • Castrop-Rauxel, Germany
        • Boehringer Ingelheim Investigational Site
      • Celle, Germany
        • Boehringer Ingelheim Investigational Site
      • Chemnitz, Germany
        • Boehringer Ingelheim Investigational Site
      • Coburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Cottbus, Germany
        • Boehringer Ingelheim Investigational Site
      • Darmstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Dillenburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Dinslaken, Germany
        • Boehringer Ingelheim Investigational Site
      • Dortmund, Germany
        • Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • Boehringer Ingelheim Investigational Site
      • Duisburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Düren, Germany
        • Boehringer Ingelheim Investigational Site
      • Düsseldorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Eisenhüttenstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Emden, Germany
        • Boehringer Ingelheim Investigational Site
      • Erbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Erfurt, Germany
        • Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • Boehringer Ingelheim Investigational Site
      • Esslingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Euskirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Fellbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Flensburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Forchheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • Boehringer Ingelheim Investigational Site
      • Freising, Germany
        • Boehringer Ingelheim Investigational Site
      • Fürstenfeldbruck, Germany
        • Boehringer Ingelheim Investigational Site
      • Fürth, Germany
        • Boehringer Ingelheim Investigational Site
      • Gadebusch, Germany
        • Boehringer Ingelheim Investigational Site
      • Geilenkirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Gelnhausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Gelsenkirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Germering, Germany
        • Boehringer Ingelheim Investigational Site
      • Gießen, Germany
        • Boehringer Ingelheim Investigational Site
      • Gifhorn, Germany
        • Boehringer Ingelheim Investigational Site
      • Gotha, Germany
        • Boehringer Ingelheim Investigational Site
      • Greiz, Germany
        • Boehringer Ingelheim Investigational Site
      • Gummersbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Göppingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Gütersloh, Germany
        • Boehringer Ingelheim Investigational Site
      • Halberstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Halle, Germany
        • Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Hameln, Germany
        • Boehringer Ingelheim Investigational Site
      • Hamm, Germany
        • Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • Boehringer Ingelheim Investigational Site
      • Heidelberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Heilbronn, Germany
        • Boehringer Ingelheim Investigational Site
      • Herne, Germany
        • Boehringer Ingelheim Investigational Site
      • Hilden, Germany
        • Boehringer Ingelheim Investigational Site
      • Hildesheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Hoyerswerda, Germany
        • Boehringer Ingelheim Investigational Site
      • Ibbenbüren, Germany
        • Boehringer Ingelheim Investigational Site
      • Ingolstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Iserlohn, Germany
        • Boehringer Ingelheim Investigational Site
      • Kaiserslautern, Germany
        • Boehringer Ingelheim Investigational Site
      • Kamen, Germany
        • Boehringer Ingelheim Investigational Site
      • Karlsruhe, Germany
        • Boehringer Ingelheim Investigational Site
      • Kaufbeuren, Germany
        • Boehringer Ingelheim Investigational Site
      • Kempten, Germany
        • Boehringer Ingelheim Investigational Site
      • Kevelaer, Germany
        • Boehringer Ingelheim Investigational Site
      • Kiel, Germany
        • Boehringer Ingelheim Investigational Site
      • Konstanz, Germany
        • Boehringer Ingelheim Investigational Site
      • Krefeld, Germany
        • Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • Boehringer Ingelheim Investigational Site
      • Landshut, Germany
        • Boehringer Ingelheim Investigational Site
      • Langenfeld, Germany
        • Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • Boehringer Ingelheim Investigational Site
      • Limburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Lindenberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Linz, Germany
        • Boehringer Ingelheim Investigational Site
      • Lippstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Ludwigsburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Lörrach, Germany
        • Boehringer Ingelheim Investigational Site
      • Lüdenscheid, Germany
        • Boehringer Ingelheim Investigational Site
      • Lüneburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Magdeburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • Boehringer Ingelheim Investigational Site
      • Marburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Markkleeberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Memmingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Menden, Germany
        • Boehringer Ingelheim Investigational Site
      • Minden, Germany
        • Boehringer Ingelheim Investigational Site
      • Moers, Germany
        • Boehringer Ingelheim Investigational Site
      • Mönchengladbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Mühldorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Mülheim, Germany
        • Boehringer Ingelheim Investigational Site
      • München, Germany
        • Boehringer Ingelheim Investigational Site
      • Neu-Ulm, Germany
        • Boehringer Ingelheim Investigational Site
      • Neunkirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Norderstedt, Germany
        • Boehringer Ingelheim Investigational Site
      • Nordhausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Nürnberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Oberursel, Germany
        • Boehringer Ingelheim Investigational Site
      • Olpe, Germany
        • Boehringer Ingelheim Investigational Site
      • Oschersleben, Germany
        • Boehringer Ingelheim Investigational Site
      • Osnabrück, Germany
        • Boehringer Ingelheim Investigational Site
      • Papenburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Peine, Germany
        • Boehringer Ingelheim Investigational Site
      • Plauen, Germany
        • Boehringer Ingelheim Investigational Site
      • Potsdam, Germany
        • Boehringer Ingelheim Investigational Site
      • Pulheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Rastatt, Germany
        • Boehringer Ingelheim Investigational Site
      • Rathenow, Germany
        • Boehringer Ingelheim Investigational Site
      • Regensburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Remscheid, Germany
        • Boehringer Ingelheim Investigational Site
      • Rendsburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Rostock, Germany
        • Boehringer Ingelheim Investigational Site
      • Rüdersdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Rüsselsheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Saarbrücken, Germany
        • Boehringer Ingelheim Investigational Site
      • Saarlouis, Germany
        • Boehringer Ingelheim Investigational Site
      • Salzgitter, Germany
        • Boehringer Ingelheim Investigational Site
      • Schenefeld, Germany
        • Boehringer Ingelheim Investigational Site
      • Schleswig, Germany
        • Boehringer Ingelheim Investigational Site
      • Schmölln, Germany
        • Boehringer Ingelheim Investigational Site
      • Schwalmstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Schwalmtal, Germany
        • Boehringer Ingelheim Investigational Site
      • Schwerin, Germany
        • Boehringer Ingelheim Investigational Site
      • Sebnitz, Germany
        • Boehringer Ingelheim Investigational Site
      • Seevetal, Germany
        • Boehringer Ingelheim Investigational Site
      • Siegen, Germany
        • Boehringer Ingelheim Investigational Site
      • Singen, Germany
        • Boehringer Ingelheim Investigational Site
      • Sinsheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Solingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Sonneberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Spremberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Stade, Germany
        • Boehringer Ingelheim Investigational Site
      • Starnberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Steinbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Straelen, Germany
        • Boehringer Ingelheim Investigational Site
      • Strausberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Stuttgart, Germany
        • Boehringer Ingelheim Investigational Site
      • Teltow, Germany
        • Boehringer Ingelheim Investigational Site
      • Teterow, Germany
        • Boehringer Ingelheim Investigational Site
      • Troisdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Unna, Germany
        • Boehringer Ingelheim Investigational Site
      • Uttenreuth, Germany
        • Boehringer Ingelheim Investigational Site
      • Verden, Germany
        • Boehringer Ingelheim Investigational Site
      • Waiblingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Waren, Germany
        • Boehringer Ingelheim Investigational Site
      • Warendorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Weiden, Germany
        • Boehringer Ingelheim Investigational Site
      • Weißenhorn, Germany
        • Boehringer Ingelheim Investigational Site
      • Wetzlar, Germany
        • Boehringer Ingelheim Investigational Site
      • Wiesloch, Germany
        • Boehringer Ingelheim Investigational Site
      • Wilhelmshaven, Germany
        • Boehringer Ingelheim Investigational Site
      • Witten, Germany
        • Boehringer Ingelheim Investigational Site
      • Worms, Germany
        • Boehringer Ingelheim Investigational Site
      • Wuppertal, Germany
        • Boehringer Ingelheim Investigational Site
      • Zella-Mehlis, Germany
        • Boehringer Ingelheim Investigational Site
      • Zossen, Germany
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients of office-based pulmonology practices

Description

Inclusion Criteria:

Men or women with COPD and a thoracic gas volume (TGV) of < 140% at rest, MRC value of 2 or more.

Exclusion Criteria:

  • Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies.
  • Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 21, 2007

First Submitted That Met QC Criteria

October 4, 2007

First Posted (Estimate)

October 5, 2007

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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